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CTD Module 1

3 August 2020

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1.9 Biopharmaceutic studies

Overview

This section of Module 1 holds documents relating to biopharmaceutic studies included in the dossier.

Summary of requirements

Documentation
Section Description Category 1/COR report-based Variations to quality only (e.g. Category 3)
New registration Variation New registration Variation
1.9.1 Details of compliance with pre-submission meeting outcomes (if meeting held) requirement defined by the regulatory activity requirement defined by the regulatory activity not required not required
1.9.2 Details of any additional data to be submitted (if agreed) requirement defined by the regulatory activity requirement defined by the regulatory activity requirement defined by the regulatory activity requirement defined by the regulatory activity

Module 1.9.1 Summary of bioavailability or bioequivalence study

When to include a summary of a bioavailability or bioequivalence study

Include for all regulatory activities which include a bioavailability or bioequivalence study in the dossier.

How to prepare a summary of a bioavailability or bioequivalence study

Download the Summary of a bioavailability or bioequivalence study form.

Complete a separate form for each study and include the forms in Module 1.9.1.

Note:

Australia's requirements for biopharmaceutic studies are aligned with the CHMP Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev1/Corr) which has been formally adopted in Australia (with annotation).

Module 1.9.2 Justification for not providing biopharmaceutic studies

When to include a justification for not providing appropriate biopharmaceutic studies

Include when biopharmaceutic studies are required as outlined in the TGA guidance on Biopharmaceutic studies, but have not been provided.

For example, when:

  • biopharmaceutic data for a generic medicine were not generated against a reference product obtained from Australia
  • a BCS (Biopharmaceutics Classification System)-based biowaiver approach is used
  • biopharmaceutic data do not cover all the different strengths for a new medicine.

How to prepare a justification for not providing appropriate biopharmaceutic studies

The justification for not providing appropriate biopharmaceutic data, including the absence of biopharmaceutic data for all strengths of the product, must:

Overseas reference product used for studies for a generic medicine

The justification for providing biopharmaceutic data for a generic medicine that was not generated against a reference product obtained from Australia needs to:

BCS-based biowaiver

A BCS-based biowaiver approach should be justified in terms of the criteria listed in CHMP Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev1 Corr) which has been formally adopted in Australia (with annotation).

Legislation

Applications for new registrations are made under section 23 of the Act.

Section. 25(1) of the Act requires medicines to be assessed for safety, quality and efficacy.

For an application to register a new generic product, as defined in Schedule 9 of the Therapeutic Goods Regulations 1990, the applicant must be able to demonstrate that the proposed medicine is bioequivalent to a registered medicine.

Applications requesting a variation to an existing registration are made under section 9D(3) of the Act.

The Secretary must be 'satisfied that the variation requested does not indicate any reduction in the quality, safety or efficacy of the goods for the purposes for which they are to be used'.

Variations that have the potential to affect the quality of the goods may require the provision of Module 1.9.2, as described above.

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